Federal health officials praise OraQuick HIV test

Group gathers at OraSure headquarters to celebrate approval of the product.

May 20, 2003|By Christian Berg Of The Morning Call

A rapid HIV test developed by OraSure Technologies received ringing endorsements from some of the nation's top public health officials Monday during a celebration at the company's Bethlehem headquarters.

Claude Allen, deputy secretary of health and human services, said the OraQuick test is "vitally important to the fight against AIDS."

Dr. Joe O'Neill, director of the White House Office of National AIDS Policy, said "the ability OraSure has given us as a public health tool is awesome."

Other officials who spoke at the event included Dr. Jack Chow, a State Department ambassador in charge of global AIDS diplomacy; William H. Gimson, chief operating officer of the Centers for Disease Control and Prevention; and Charles Curie, administrator of the Substance Abuse and Mental Health Services Administration.

Despite their public praise for OraQuick, which can detect the AIDS virus in only 20 minutes, none of the officials had details about how many tests the federal government will buy from OraSure or when those orders will come.

Even OraSure Chief Executive Officer Michael Gausling isn't sure how long it will take before the government's recognition turns into a financial benefit. "I wish I had good answers," Gausling said. "I don't yet, but people are keenly aware of what we do."

OraSure organized Monday's event to recognize the early success of its OraQuick test. In November, it became the only rapid, easy-to-use HIV test approved by the Food and Drug Administration. Earlier this year, President Bush announced a waiver that allows OraQuick to be used at more than 100,000 sites nationwide, including physicians' offices and HIV counseling centers.

OraQuick sales have been strong since. OraSure produced 280,000 OraQuick tests at its Eaton Avenue plant in Bethlehem during the first quarter and sold all of them. OraSure said OraQuick sales for the three months ended March 31 were $1.4 million higher than for the same period a year ago, which helped boost first-quarter sales to a record $8.6 million.

As a result, the company has bought equipment needed to double production to 300,000 tests a month by the end of June.

Chow said Monday that OraQuick will be a key component of Bush's five-year, $15 billion plan to fight AIDS in 14 African and Caribbean nations with high HIV infection rates.

Africa has 30 million HIV-infected people, including 3 million children under age 15. Of those, only 1 percent receive drug treatment. Allen of the Department of Health and Human Services estimated that the U.S effort will prevent 7 million new HIV infections and provide drug treatment for 10 million infected people.

Bush's plan, which received congressional approval last week, could mean a significant boost in OraQuick sales. Although details aren't available, Chow envisions medical teams taking OraQuick tests with them when they travel to remote African villages.

OraQuick should be an important part of domestic AIDS prevention too. Last month, the CDC introduced a sweeping AIDS prevention initiative that puts a priority on rapid testing. The CDC is urging federally funded clinics, jails, shelters, substance abuse treatment centers and other locations to take advantage of OraQuick.

"We're very excited about the potential benefits of OraQuick," Gimson said Monday.

OraQuick is about as easy to use as a home pregnancy kit, health officials say. To use the pocket-size test, a health worker pricks a person's finger, mixes a spot of blood into a vial of developing solution and drops in the stick-like testing device.

OraQuick is revolutionary because its speed lets patients learn their HIV status before leaving a clinic or medical office. In most cases, it can replace traditional lab tests that make people wait a week or more for results.

"Knowing your HIV status can increase your life expectancy significantly if you seek treatment early," Allen said. He noted that at least 8,000 Americans test positive for HIV each year in public health clinics but never return for their test results.

Jim Driscoll, an adviser to the AIDS Healthcare Foundation who attended Monday's event, said the foundation's 14 clinics, mostly in California, hope to begin using OraQuick within six months.

"At our AHF clinics, we have just routine regular testing for people -- the type where you have to wait two weeks," Driscoll said. "We're anxious to get" OraQuick.

Driscoll, who is also a member of the Presidential Advisory Council on HIV/AIDS, said he sees OraQuick as the first-choice among HIV tests that AHF clinics will administer.

"We're hoping there will be a grant from CDC to kind of jump-start the program to pay for two million kits and provide them to clinics like ours around the country."

The CDC estimates that between 850,000 and 950,000 Americans are infected with HIV -- including 24,000 people in Pennsylvania and more than 800 in the Lehigh Valley. About a quarter of those infected don't know it.